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Insmed Incorporated Message Board

  • risingedge77 risingedge77 Mar 11, 2014 1:18 AM Flag

    From Form 10-K, Next Expected Milestones for Pa...

    • We expect to submit regulatory filings with the EMA and Health Canada in the middle of 2014. If the EMA allows a filing that includes both the CF and NTM indication we will most likely submit our filing in the second half of 2014.
    • We expect to evaluate our plans for this indication in the United States after reviewing the results from our phase 2 clinical trial in NTM.
    • We are developing plans to commercialize ARIKAYCE, if approved, in certain countries in Europe and in Canada where we expect it would be the only once-a-day treatment for Pa lung infections in CF patients.

    Sentiment: Buy

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    • Hmm ... "a filing that includes both the CF and NTM indication" .....

      All we ever needed to warrant a current market valuation of well over $20 was just one approval for one indication.

      With both long-term efficacy and safety data already in the bag it seems all but inevitable that Arikace will go on sale in Canada sooner rather than later.

      If, at that point, it isn't yet on sale in the US there will be substantial off-label use by US CF and NTM patients.

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